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FDA 510(k)

FemVue® Controlled Saline-Air Device (FSA-300)

K-Number: K253403 · 2025-12-15

ApplicantFemasys, Inc.
Decision Date2025-12-15
Product CodeLKF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FemVue® Controlled Saline-Air Device (FSA-300) is a medical device manufactured by Femasys, Inc.. It received FDA 510(k) clearance on 2025-12-15 under approval number K253403. The device is classified under product code LKF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FemVue® Controlled Saline-Air Device (FSA-300)?

FemVue® Controlled Saline-Air Device (FSA-300) is a medical device that received FDA 510(k) clearance on 2025-12-15. It is manufactured by Femasys, Inc.. The 510(k) number is K253403.

When was FemVue® Controlled Saline-Air Device (FSA-300) approved by the FDA?

FemVue® Controlled Saline-Air Device (FSA-300) received FDA 510(k) clearance on 2025-12-15, under approval number K253403.

What company makes FemVue® Controlled Saline-Air Device (FSA-300)?

FemVue® Controlled Saline-Air Device (FSA-300) is manufactured by Femasys, Inc..

What is the FDA product code for FemVue® Controlled Saline-Air Device (FSA-300)?

The FDA product code for FemVue® Controlled Saline-Air Device (FSA-300) is LKF.

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Related PubMed Literature

PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 41477286 Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial. Journal of pharmacopuncture (2025) PMID: 40469887 Postmarket Safety Surveillance of FDA-Cleared Prescription Digital Therapeutics Using the Manufacturer and User Facility Device Experience (MAUDE) Database: A Pharmacovigilance Study. Cureus (2025)

Other Devices by Femasys, Inc.

K231730FemaSeed Intratubal Insemination K242002FemVue MINI Saline-Air Device K241693FemChec Controlled Saline-Air Device (FCD-250)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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